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Ocugen Seeks Emergency OK for Covid-19 Vaccine for Children, Lifting Shares Premarket

By Robb M. Stewart

 

Ocugen Inc. on Friday said it has requested emergency-use authorization for a Covid-19 vaccine for children as young as 2 years old, buoying its shares before the opening bell.

Children as young as 5 have begun receiving the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, the first shot U.S. federal health regulators have permitted.

In premarket trading, Ocugen's shares were 2.4% higher after climbing by more than 6% earlier in the morning. They ended Thursday at $10.06, having surged since last December.

Ocugen said it has submitted a request for emergency-use authorization for BBV152, known as Covaxin outside the U.S., for pediatric use. The vaccine candidate was developed by the company's partner, Bharat Biotech.

The FDA a week ago authorized the Pfizer-BioNTech vaccine for children age 5 to 11. The shot had been authorized for people 16 years and older since last December and cleared for those 12 and older since May.

Ocugen said its regulatory submission is based on the results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children ages 2-18, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.

The neutralizing antibody responses against wild-type strain in the pediatric group of 2-18 year old were equivalent to those seen in adults ages 18 and older in Bharat Biotech's large Phase 3 efficacy and safety trial, Ocugen said. The results suggest similar protection in children ages 2-18 to that demonstrated in adults older than 18 years, it said.

Covaxin recently received an emergency-use listing by the World Health Organization.

 

Write to Robb M. Stewart at robb.stewart@wsj.com

 

(END) Dow Jones Newswires

November 05, 2021 09:12 ET (13:12 GMT)

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